ECHA Publishes Practical Guide for Reporting Toxicity Data for REACH

ECHA has announced that it has made available a new "practical guide" to assist REACH registrants in "How to prepare toxicological summaries in IUCLID and how to derive DNELs." The guide "supports registrants in correctly summarising the toxicological information for substances in section 7 of IUCLID 5.4."

The most critical part of the guide explains how to undertake the take of "Derivation of No Effect Levels" (DNELs), which are used to compare toxicity to exposure in the assessment of risk. DNELs must be derived for all relevant toxicological endpoints (e.g., oral and dermal exposures) and represent the effects side of the equation for human health concerns. For environmental concerns there is a similar derivation of "Predicted No Effect Levels" (PNECs) for aquatic and terrestrial organisms. PNEC derivation is not discussed in the new practical guide.

More information on the Practical Guide can be found on the ECHA web site.

The Practical Guide in PDF format can be downloaded directly here.

Japan Identifies 18 Chemicals for Closer Look after Priority Risk Assessments

After an extensive review of 86 chemicals, including detailed environmental and human health risk assessments, the Japanese government has identified 18 chemicals for closer review. The Tier I assessments resulted in five chemicals classified as substances that would be further monitored for production or import volume, mainly because they were considered likely to have fairly low levels. But 18 chemicals were deemed to be of significant enough potential risk to necessitate the Tier 2 assessments. Tier 2 assessments include requirements for manufacturers and importers to provide both health and safety hazard data and exposure information.

Eleven chemicals were identified based on their presumed risk to human health:

• hydrazine
• 1,3-butadiene
• dichloromethane
• 1,2-dichloropropane
• chloroethylene
• ethylene oxide
• 1,2-epoxypropane
• formaldehyde
• acrylonitrile
• toluidine

Seven chemicals were identified based on their presumed risk to the environment:

• 1,3-dichloropropene
• n-butyl acrylate
• isopropenylbenzene
• dichlorobenzene
• 2,6-di-tert-butyl-4-methylphenol
• [3-(2-ethylhexyloxy)propylamine]triphenylboron
• 4,4'-(propane-2,2-diyl)bis(phenol)

The Japanese government will perform the assessments in accordance with Japan's Chemical Substance Control regulation.

EU to Update Stockholm Convention POPs Chemical Plan

The European Commission (EC) has announced that it is reevaluating and updating the implementing plan for the Stockholm Convention on Persistent Organic Pollutants. The Stockholm Convention is a "global treaty to protect human health and the environment from chemicals that remain intact in the environment for long periods, become widely distributed geographically and accumulate in the fatty tissue of humans and wildlife." A plan was originally drawn up in 2007 and "a significant number of the actions identified in the 2007 Plan have now been finalized or are about to be finalised." Hence the need for an update.

A consultation has been opened on the European Commission web site and interested parties have between August 2 to October 25, 2012 to provide comment.

The full consultation document is available as a PDF download here.

ECHA to make more data on chemicals available

According to an ECHA news release:

"Beginning in November, ECHA will make more information from registration dossiers available on its website. This will implement a decision taken by ECHA in 2011 and is in line with Article 119(2)d of REACH. With these new elements, information made available will include the name of the registrant, the registration number of the substance as well as other items normally contained in a Safety Data Sheet (SDS). Companies wishing to request confidentiality on these items need to update their dossiers and justify their requests for confidential treatment."

 More information can be found on the ECHA web site.

Senator Lautenberg Calls for Senate Vote on Safe Chemicals Act

Senator Frank Lautenberg (D-NJ) is calling for a vote in the full Senate on his Safe Chemicals Act. Originally introduced April 14, 2011, the bill was passed out of the Environment and Public Works Committee last week. The bill is "designed to protect Americans from dangerous toxic chemicals that are found in everyday consumer products." Lautenberg now wants the bill to get a vote in the Senate.

A 174-page Amendment that documents all of the changes to the original bill (S.847) was released by the Committee. The committee also issued a short summary highlighting the key changes. These changes comprehensively alter the bill from its original "NGO-friendly" form to its now very "Industry-friendly" form. Still, Lautenberg has not been able to get any Republican to join the 25 Democratic co-sponsors of the bill. Lautenberg called on his fellow Senators to put the bill to a vote,  "either for or against." He noted that "families deserve to know" what Senators from both sides of the aisle "are thinking as we go through this process."





After languishing for nearly one and half years after its introduction, the bill took on new emphasis following an investigative reporting series by the Chicago Tribune. The Tribune reported that there had been collusion between the chemical industry and the tobacco industry to overstate the effectiveness of flame retardants and understate the health risks. A rather contentious hearing was held the day before the Committee vote, during which Senator Boxer went so far as to suggest one of the witnesses should "take a course in ethics."

It is clear that Lautenberg does not expect the bill to pass a full Senate vote since it would need to reach 60 votes to invoke cloture just to bring it to the floor for a real vote. With only 53 Democrats and Independents possibly voting for the bill and all 47 Republicans likely voting against it no matter what changes are made in debate, the bill is essentially dead on arrival. But he does feel that after 7 years of introducing bills and making substantive changes that make the bill more industry-friendly, the public should know what each Senator believes about protecting human health and the environment.

EPA Issues Analysis of Alternatives for Bisphenol A (BPA) Uses

The USEPA has issued a draft analysis of alternative chemicals that can be used instead of Bisphenol A (BPA) in thermal paper. According to EPA's Design for the Environmenet (DfE) program:

This draft report is an assessment of 19 chemical alternatives that may substitute for BPA, which is used as a developer in thermal paper. In addition, this report provides background information about how thermal paper is made, and considerations for choosing an alternative. A chemical's inclusion in the report does not constitute EPA endorsement. This draft report does not identify functional chemicals with low concern for all human health and environmental hazard endpoints; all of the alternatives are associated with some trade-offs.

The focus on thermal paper is because it "is widely used for cash register receipts, airline tickets, event and cinema tickets, and grocery store adhesive labels" and because this narrow focus was one area where alternatives exist. In addition, "workers in certain occupations, such as cashiers and restaurant servers who handle thermal paper often, may be at greater risk of exposure." Young children and teenagers entering the workforce may have especially high exposures. Concerns for BPA exposure include endocrine disruption and neurological changes.

The full 492-page PDF can be viewed or downloaded here.

The draft analysis can also be read online as smaller files here.

EPA Identifies Substitutes for Toxic Flame Retardant Chemical

The USEPA has released a draft report on alternatives to the "toxic flame retardant chemical known as decabromodiphenyl ether (decaBDE)." Acting Assistant Administrator Jim Jones had mentioned at a Senate hearing last week that the Agency was in the final steps of eliminating DecaBDE from products. This new action is part of EPA's Design for the Environment (DfE) program. The draft report being released "profiles the environmental and human health hazards on 30 alternatives to decaBDE, which will be phased out of production by December 2013."

EPA notes that "the alternatives to decaBDE characterized in the report are already on the market and will be used increasingly as decaBDE is phased out." EPA also notes that while overall the alternatives are considered good replacements for decaBDE, they have "differing hazard characteristics and are associated with trade-offs."

More information can be found in EPA's news release.

The full 812-page alternatives assessment for decaBDE can be viewed as a PDF here.

More information about the flame retardants alternatives project can be found here.

More information on EPA's DfE program can be found here.

Andrew A. Rosenberg to Lead New Center for Science and Democracy

The Union of Concerned Scientists (UCS) has announced that  Andrew Rosenberg is joining the Union of Concerned Scientists (UCS) to serve as director of its new Center for Science and Democracy.  Rosenberg previously "served as the Northeast regional administrator of the National Oceanic and Atmospheric Administration’s National Marine Fisheries Service," and later as NMFS's deputy director. He is also the convening lead author of the oceans chapter of the U.S. Climate Impacts Advisory Panel. Most recently he was at Conservation International, where he was the senior vice-president for Science and Knowledge.

 The goal of the new Center for Science and Democracy is to restore" the essential role of science, evidence-based knowledge, and constructive debate in the U.S. policymaking process, using three core strategies:"

• Restoring public confidence in, and support for, the use of independent science in public policy making;
• Helping decision makers, citizens and journalists distinguish evidence-based information from propaganda;
• Working with scientists to help them become more effective communicators and policy contributors.

More information on the new Center for Science and Democracy can be found here.

Information on the other activities of the Union of Concerned Scientists can be found here.

Senate Passes Safe Chemicals Act out of Committee

The Senate committee charged with reforming the 1976 Toxic Substances Control Act (TSCA) has voted to send the bill proposed by Senator Frank Lautenberg to the full Senate for open debate and a possible vote. As expected after Tuesday's contentious hearing, the committee vote split along party lines with the ten Democrats voting for it and the eight Republicans voting against it.

Republicans argued that the vote on the bill introduced one and a half years ago was premature, and that there had not been time for the "bipartisan" discussions to reach fruition. Democrats countered that the bill had been substantially revised many times following dozens of hearings, stakeholder meetings, and private consultations with the Republican members. Senators Boxer and Lautenberg felt that it was important to get everyone's views out in the open so that their constituents could make judgments on whether to support the bill.

Indeed, the committee issued a 174-page Amendment that documents all of the changes to the original bill (S.847). They also issued a short summary highlighting the key changes.

Many of the changes incorporate the concerns of industry and the Republican minority. For example, the original bill introduced in 2005 would have required all chemical manufacturers to undertake a REACH-style data development in which all chemicals would need a substantial amount of health and safety data to be submitted prior to manufacture or in order to keep existing chemicals on the market. To incorporate industry concerns, the version passed by the committee yesterday "better focuses resources on priority chemicals" while continuing to require EPA to do most of the work of determining if a chemical is not safe. Existing chemicals would be evaluated in batches and screened through a prioritization process, then undergo safety determinations in order of priority.

The changes also require new information and testing "only when necessary." Data could be provided through means other than new testing when appropriate and defensible, for example, using QSARs, read-across, and non-animal studies.

Confidential business information (CBI) provisions have also been revamped to address industry concerns, and the new bill "better balances protection" of CBI versus the public's right to know about the chemicals to which they may be exposed.

As noted yesterday, it is highly unlikely that the Safe Chemicals Act will ever be passed by the Senate during this session of Congress, and even if it did come to a vote would likely never meet the 60-vote supermajority needed to even get to the actual up or down vote on the bill itself. And even if it somehow got that far, the House is highly unlikely to consider any bill at all. Facing this uphill battle the sponsors of the bill (Lautenberg and 21-cosponsors, all Democrats) felt it necessary to move the bill forward to all open expression of the conflicting views.

Information on the bill can be reviewed on the Thomas Library of Congress site.

Senate Moves TSCA Bill to Vote After Contentious Hearing

[Update: The Safe Chemicals Act has been approved by vote of the Committee on July 25, 2012] As noted yesterday, the Senate held a hearing on "EPA's authorities to control toxic chemicals." The hearing built on many previous hearings to gather information relevant to the reform of the TSCA chemical control law.  The hearing began fairly benignly but ended rather contentiously, with Senators Barbara Boxer (D-CA) and Frank Lautenberg (D-NJ) preparing for a markup of the Safe Chemicals Act bill today, July 25, 2012.

The hearing ostensibly was in response to an investigative series published recently by the Chicago Tribune. The Tribune series argued that "two powerful chemical industries - Big tobacco and chemical manufacturers - waged deceptive campaigns that led to the proliferation" of flame retardant chemicals such as the PBDEs. Witnesses during the hearing included Dr. Heather Stapleton, an expert on flame retardant chemicals at Duke University, and Marshall Moore, Director of Technology, Advocacy and Marketing at Chemtura, a manufacturer of PBDEs and one of the companies specifically identified by the Chicago Tribune.

In their opening statements the Senators offered reiterations of their usual positions. Democrats focused on the toxicity, persistence and bioaccumulation of PBDEs in particular and chemicals in general. Republicans, in particular Senators James Inhofe (R-OK) and David Vitter (R-LA), expressed their disappointment that the Democratic majority of the committee was planning to bring Lautenberg's Safe Chemical Act bill to markup. Republicans felt that this meant the end of the "bipartisan" discussions in which Democratic and Republican members of the committee and their staffs had engaged for the year and a half since the introduction of Lautenberg's bill.

Democrats countered that the "bipartisan" discussions were going nowhere and it was time to get Republican views out in the open with a markup and committee vote on the bill. Lautenberg reminded his colleagues that he first introduced a version of the Safe Chemicals Act in 2005 and that over the last seven years there had been dozens of hearings, meetings, and consultations with Republicans on the best way to reform TSCA. All stakeholders have agreed publicly many times that TSCA is in dire need of reform, a position EPA acting Assistant Administrator Jim Jones reiterated in his testimony. Indeed, Lautenberg's Safe Chemicals Act bill has clearly migrated from a more NGO-approved (all data for all chemicals) approach in the original to a more Industry-friendly (prioritization) approach in the current version. The markup is an attempt by Democrats to put the Republican position on record given that passage of a TSCA reform bill is highly unlikely in this Congress, and perhaps impossible in the next Congress depending on the results of this fall's election.

Democrats were clearly frustrated with the Republicans during the hearing. This became especially evident during the second panel in which Senator Boxer repeatedly made it clear which witnesses were called by the majority party (Democrats) and which were called by the minority party (Republicans). Boxer also repeatedly praised the courage of mother and former Maine House leader Hannah Pingree, who had said during questioning that "the chemical industry does not always tell us the truth." Boxer similarly praised the work of fireman Tony Stefani, who heads a Firefighters Cancer Prevention Foundation, which he started after he and his fellow firefighters were found to have higher incidences of the kind of cancers that he claims "are usually seen in workers in chemical manufacturing."

In contrast, Boxer several times addressed chemical manufacturing representative Marshall Moore in ways that can euphemistically described as "direct." She told Moore that "he needs to apologize" for "grossly distorting" a study on which he relied for demonstrating effectiveness and safety of flame retardant chemicals. Boxer also told Moore that "take a course in ethics" because the industry had set up a "phony fire safety group" (based on the charges in the Tribune series). Moore was remarkably calm and respectful given Boxer's direct accusations and insisted that his company and others had conducted and provided to EPA dozens of studies to aid the assessment.


The hearing demonstrated that TSCA reform, despite the repeated public assurances by all stakeholders that modernization was necessary and desirable, is likely not going to happen. As noted, while the Republicans expressed their disappointment that the bill will go to markup and probably to a committee vote, Democrats expressed their continued desire to work on a bipartisan bill, which they now believe can better be accomplished by an open debate on the Senate floor where each individual Senator would be able to put their views on record.

Of course, even in the unlikely event that a bill could be passed in the Senate (virtually all bills now must pass 60 votes for cloture before they can even make it to the floor for a vote), there is essentially no chance that the Republican-controlled House would even take up a companion bill.


More information and downloads of the testimony can be found on the committee hearing page.

TODAY - Senate Hearing on Exposures to Toxic Chemicals

There will be a Senate hearing today, Tuesday, July 24, 2012 to hear witnesses on the topic "Oversight on EPA Authorities to Control Exposures to Toxic Chemicals." The hearing is being held by the Full Senate Environment and Public Works Committee and its Subcommittee on Superfund, Toxics, and Environmental Health. The subcommittee is chaired by Senator Frank Lautenberg (D-NJ) who has been working for several years to modernize the Toxic Substances Control Act (TSCA) originally passed in 1976.

Lautenberg and other Democratic members of the committee are planning a markup and vote on his Safe Chemicals Act bill on Wednesday. Republican members immediately balked at the idea, noting that they were not given any warning of the vote. At the previous hearing by this subcommittee many months ago, Democrats had practically begged Republicans and industry to "give us a bill," i.e., rather than merely say the current bill was inadequate, actually propose a bill that Republicans and industry could live with given that all parties claim to want a workable modernization of TSCA. Republicans and industry declined to do so.

While the Safe Chemicals Act - TSCA reform - has been largely ignored during this election year, it has received renewed interest lately as the result of a Chicago Tribune investigative series that accused the chemical industry of misleading the public and regulators about both the effectiveness and safety of brominated flame retardants.

Today's hearing begins at 10:00 am ET in room 406 of the Dirksen Senate building. The hearing will be webcast. The full agenda and list of witnesses is below:

Opening Remarks

Panel 1

The Honorable Jim Jones Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention U.S. Environmental Protection Agency

Panel 2

Hannah Pingree Mother, Former Speaker of the Maine House of Representatives

Dr. Heather M. Stapelton Assistant Professor of Environmental Chemistry, Environment Sciences & Policy, Nicholas School of the Environment Duke University

Marshall Moore Director, Technology, Advocacy and Marketing Great Lakes Solutions, A Chemtura Business

William K. Rawson Partner, Chair, Environment, Land & Resources Department Latham & Watkins LLP

Tony Stefani President, Founder San Francisco Firefighters Cancer Prevention Foundation

 

Poll Shows Most Americans Want to Update Chemical Control Law

A new poll conducted by Public Opinion Strategies, a leading Republican polling firm, shows that "voters are concerned about the effects of exposure to toxic chemicals in day to day life." The poll also shows that "most voters support 'stricter regulation of chemicals produced and used in everyday products.'"

POS conducted the national telephone survey of 800 registered voters on June 25-27, 2012. The overall margin of error is +3.46%. Interviews were distributed proportionally throughout the country. More information on the poll results and methods can be found here.

Poll results show that 77% of respondents support specific legislation to reform the Toxic Substances Control Act (TSCA), the law passed in 1976 for which all stakeholders (industry, NGOs, EPA, health and environmental advocates) agree needs to be modernized. Support for reform of the law was "wide-spread and broad-based," i.e., large majorities of all demographics surveyed agreed that the law was in need of updating.

POS concluded that "U.S. voters overwhelmingly support reform to regulations overseeing chemicals produced and used in everyday products, particularly when provided with specifics about what the reform might entail." Even when robust arguments on both sides of the issue were presented, "voters continue to side with supporters of reform."

TSCA reform has been the subject of many attempts by Senator Frank Lautenberg (D-NJ) and others to introduce legislation. Lautenberg's most recent effort, the Safe Chemicals Act, has languished in Committee without action. This might change this week, however, as Lautenberg says he expects to bring the bill to markup this week, which may lead to a Committee vote as early as Wednesday.

Meanwhile, the subcommittee and full committee of the Senate Environment and Public Works Committee has scheduled a hearing for Tuesday, July 24th to discuss Congressional oversight of EPA authorities related to TSCA. Of specific interest is a recent investigative series by the Chicago Tribune that suggested the brominated flame retardant industry had overstated benefits and understated risks of a class of flame retardants called PBDEs. This builds on a hearing held recently by Senator Dick Durbin (D-IL).

Senator Durbin Holds Hearing on Brominated Flame Retardants

Senator Dick Durbin (D-IL) held a hearing on Tuesday, July 17, 2012 regarding the question:

AreConsumers Adequately Protected from Flammability of Upholstered Furniture?  Hearing on the Effectiveness of FurnitureFlammability Standards and Flame Retardant Chemicals.

Durbin's concern stems from a recent Chicago Tribune investigative series that suggested the flame retardant industry had misled regulators on both the effectiveness and safety of a class of brominated flame retardants called PBDEs. The Senator is a strong supporter of overhauling the 26-year old TSCA law and is a co-sponsor of the Safe Chemicals Act introduced by Senator Frank Lautenberg (D-NJ).


Scheduled witnesses at the July 17th hearing were:

 

Panel I

·        The Honorable Inez Tenenbaum, Chairman, Consumer Product Safety Commission.

·        James J. Jones, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency.

Panel II

·        August (Gus) Schaefer, Sr., Vice President and Chief Safety Officer, Underwriters Laboratories, Inc.

·        Andy Counts, CEO, American Home Furnishings Alliance.

·        Peter Van Dorpe, Chief of the Training Division for Chicago Fire Department.

More information on the hearing can be found here.

New EU Biocide Regulation Enters Into Force

The new Biocidal Products Regulation (BPR) enters into force in the EU today, July 17, 2012. The BPR replaces the Biocidal Products Directive (BPD) that had been the law governing biocides. There will be a transition period for some biocidal products already in the review process, but the new BPR moves much of the responsibility for approving biocides to the European Chemicals Agency (ECHA).  ECHA is also responsible for REACH, the chemicals regulation.

As a regulation, the BPR goes into force in all of the EU immediately.  The previous Directive had to be implemented by individual member state action.

More information on the new Biocidal Products Regulation can be found on ECHA's web site.